A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

UCB Biopharma SRL

Summary

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

Eligibility

Age range: 12+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participant must be ≥12 years of age at the Baseline/Randomization Visit * Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; the study caregiver(s) must be able to recognize and observe the participant's seizures * Participants with an established diagnosis of focal or generalized epilepsy or combined…

Interventions

Drug
Staccato alprazolam
Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
Other
Placebo
Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.

Summary

Eligibility

Interventions

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